- Lilly (Indianapolis, IN)
- …and practical experience with medical device / combination product quality & regulatory requirements, including GMP/CFR, EU MDR, ISO and IEC requirements ... will provide leadership for Commercialization Global Program Managers (GPM's) who lead medical device and drug/ device combination product commercialization… more
- Edwards Lifesciences (Irvine, CA)
- …role will provide high- quality guidance and support to Edwards' leaders on medical device commercial, clinical, regulatory , quality and reimbursement ... legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this... guidance and support to Edwards' on healthcare and medical device regulatory matters, including… more
- Cardinal Health (Boston, MA)
- …**_Qualifications_** + Bachelors in related field, preferred + 2+ years' experience in Medical Device Regulatory Affairs/ Quality experience preferred + ... affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This… more
- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... to advance patient outcomes and set new standards of care. **SUMMARY** The Quality Control Technician II will be responsible for performing Quality Control… more
- West Pharmaceutical Services (Walker, MI)
- …engineering **Work Experience** + Minimum 10+ years in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs, or a ... execution of Quality Management System Compliance to Medical Device and Pharmaceutical regulations for Combination...regulatory requirements such as 21CFR Part 820 for Medical Devices and 21CFR Part 210, 211 & Part… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... for CE Marking. The Senior Specialist ensures timely and high- quality execution of all regulatory deliverables. In...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Medtronic (Tempe, AZ)
- …QSR, ISO standards, and related regulations. + Previous knowledge of medical device quality systems and regulatory requirements. + Familiarity with lean ... workplace environment that reflects Medtronic's standing as the world's top medical device company. Help us engineer the extraordinary! Do meaningful work, make… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's ... Assurance group and reports to the Senior Manager, Medical Device External Quality . The...internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality … more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
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